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NHLBI SMARTT Program Awards AlphaCore Pharma Funding to Manufacture Potential Treatment for Familial Lecithin-Cholesterol Acyltransferase (LCAT) Deficiency

Tue, 02/14/2012 - 4:45am
The Associated Press

ANN ARBOR, Mich. & ROCKVILLE, Md.--(BUSINESS WIRE)--Feb 14, 2012-- AlphaCore Pharma, a biopharmaceutical company, and Advanced Bioscience Laboratories (ABL), a biomedical contract research and manufacturing company, today announce funding from the National Institutes of Health, National Heart, Lung and Blood Institute (NHLBI) "Science Moving towards Research Translation and Therapy" (SMARTT) program, to manufacture recombinant human lecithin-cholesterol acyltransferase (rhLCAT) for the treatment of familial LCAT deficiency.

Also known as ACP-501, rhLCAT represents a promising new approach in the fight against atherosclerotic cardiovascular disease, and has demonstrated preclinical efficacy in promoting HDL maturation and cholesterol flux, a natural process by which cholesterol is removed from the body. Currently, ACP-501 is in Phase 1 clinical development with the eventual goal of reducing the risk of cardiovascular events in patients presenting with acute coronary syndrome. Manufacturing support from the NHLBI SMARTT program will enable production of additional material that will be used to determine the safety and efficacy of rhLCAT enzyme replacement therapy for patients with familial LCAT deficiency - a potentially life-threatening illness for which there is no FDA-approved treatment.

"This is a significant step towards developing a treatment for familial LCAT deficiency. We are pleased by the strong support from the NHLBI and ABL and look forward to advancing this program." said AlphaCore President, Bruce Auerbach.

The enzyme, rhLCAT, will be produced by ABL in its Rockville, MD biologics production facility under a contract from the NHLBI SMARTT program. Dr. Thomas VanCott, ABL's President and Chief Executive Officer stated, "ABL is privileged to be working with AlphaCore Pharma in support of their ACP-501 (rhLCAT) program. Research in rare genetic diseases can encounter funding hurdles, yet through this NHLBI-sponsored manufacturing project we have the potential to advance an urgently needed enzyme replacement therapy. This effort further demonstrates ABL's expertise of partnering with the NIH to support major development programs and our commitment to deliver the highest quality cGMP biologics to our clients in a cost-effective manner." About AlphaCore Pharma AlphaCore Pharma is an Ann Arbor-based private company focused on the development of ACP-501 (recombinant human lecithin: cholesterol acyltransferase or rhLCAT) as a therapy for acute coronary syndromes, and other high-risk atherosclerosis conditions. Additionally, ACP-501 is being developed to treat familial LCAT deficiency (an orphan designated enzyme replacement therapy) and other diseases where LCAT activity is low. Additional information on AlphaCore Pharma is available at www.alphacorepharma.com.

About ABL Advanced BioScience Laboratories, Inc. (ABL) is a Maryland-based biomedical contract research and manufacturing organization dedicated to advancing the development of therapeutics, vaccines and other biologic products. ABL has extensive experience working with diverse organizations, including various government and academic entities and commercial bio/pharmaceutical companies. Notable services include basic research, product design, process and assay development, preclinical in vivo models (including immunomonitoring), and Phase I/II cGMP biologics manufacturing. Since 2001 ABL has been a part of the Institut Merieux, a group of companies dedicated to developing translational science for better patient care globally. For more information on ABL and our services, please visit our website at www.ablinc.com.

About NHLBI Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov/. Information about the SMARTT program is available at https://www.nhlbismartt.org/.

CONTACT: AlphaCore Pharma Contact: William Brinkerhoff 734-619-8801 or ABL Contact: Andrew Arrage Vice President, Business Development 301-816-5209 KEYWORD: UNITED STATES NORTH AMERICA MARYLAND MICHIGAN INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH SCIENCE SOURCE: Advanced BioScience Laboratories, Inc. (ABL) and AlphaCore Pharma Copyright Business Wire 2012 PUB: 02/14/2012 09:17 AM/DISC: 02/14/2012 09:17 AM http://www.businesswire.com/news/home/20120214006024/

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